When a medicinal product (drug or biologic) meets a medical device, a combined product is created. Incompatibility between the components can present a danger to the patient, but how can one demonstrate the fit between a medicinal product and a device? This whitepaper delves into this critical issue, providing detailed insights into the challenges and solutions associated with combined products.
This comprehensive whitepaper begins by defining the relevant terms and concepts related to combined products, helping readers understand the scope and complexity of these innovations. It outlines the existing regulatory framework for combined products, highlighting the current gaps and ambiguities in regulatory guidance. It also provides a clear picture of the regulatory landscape, enabling stakeholders to navigate the complexities more effectively.
A significant focus of this whitepaper is on stability testing, a crucial process for assessing the compatibility between the drug or biologic and the medical device. Readers will learn how to design and implement stability testing protocols that ensure the safety and efficacy of combined products.
Whether you are developing new combined products or seeking to improve existing ones, this whitepaper offers valuable information and practical advice to help you achieve compatibility and regulatory compliance.